Effect of BMY halt on Sunrise enrollment. Thanks Bio and CP for your very good posts on why Sunrise enrollment won’t be affected. I believe there is one more important point.
Pretend you are a US lung cancer patient with late stage NSCLC and Opdivo has somehow, miraculously, been approved, and labeled and is on the market before Sunrise enrollment completes (e.g., 3 months from now instead of the anticipated 4-6 months). You want to get access to the latest and greatest treatment for advanced NSCLC to extend your survival time so you ask your Dr. whether you should start taking Opdivo or go into the Sunrise trial. If your Dr. has heard SK speak at a visit to this trial site or at one of the many preclinical Bavi data dumps (including AACR tomorrow) then he is likely to answer the question this way: If you enter the Sunrise trial you have a 50% chance of being in the treatment arm and there is very strong evidence that Bavituximab will trigger an immune response that will increase your survival time substantially with very manageable sided effects. If you start an Opdivo regimen you have a 70% chance it won’t work for you and you have a good chance of experiencing serious side effects that we may be able to manage but we don’t understand these immune system side effects as well as we understand chemo side effects.
I acknowledge there is room for debate, but given the very positive feedback from Sunrise investigators that SK reported in the March CC, there is a good chance the Dr. would steer the patient into the chemo path with AEs he understands rather than the Opdivo path with immune system AEs that he doesn’t often see.
Of course as discussed in Bio’s and CP posts, the main points are that (1) Opdivo won’t be approved in the U.S for non-squamous NSCLC in time to affect enrollment at the US sites, (2) Opdivo will not be available at any of the non-US sites, and (3) the largest factor impacting enrollment will be the total number of other trials also recruiting similar NSCLC patients, and now that the BMY trial is finished Bavi has one less competitor to deal with.
